OP0142 EFFICACY AND SAFETY OF TELITACICEPT, A NOVEL BLYS/APRIL DUAL INHIBITOR, IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME: A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED 24-WEEK STUDY
Authors: D. Xu, S. Zhang, C. Huang, C. Huang, L. Qin, X. Li, M. Chen, X. Liu, Y. Liu, Z. Li, J. Hu, C. Bao, W. Wei, J. Tian, X. Duan, R. Van Vollenhoven, J. Fang, X. Zeng
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Primary Sjögren's syndrome (pSS) is a chronic systemic autoimmune disease characterized by B-cell hyperactivity. There are still currently no systemic treatments approved for pSS. Telitacicept (TACI-Fc fusion protein) is a novel BLyS (B-lymphocyte stimulator)/APRIL (a proliferation-inducing ligand) dual inhibitor, which has been approved in 2021 in China for the treatment of patients with active systemic lupus erythematosus (SLE)[1]. <h3>Objectives</h3> To evaluate the efficacy and safety of telitacicept in patients with pSS. <h3>Methods</h3> In this phase 2, placebo-controlled study, 42 patients with active pSS (ESSDAI score ≥5) were randomized to 3 treatment arms: placebo (N=14), telitacicept 160 mg (N=14) and telitacicept 240 mg (N=14). Study drugs were administered subcutaneously weekly for 24 weeks. The primary endpoint was the change from baseline in the ESSDAI score at week 24. Key secondary endpoints included: ESSPRI, MFI-20, immunological biomarkers including IgG, IgA, IgM and CD19<sup>+</sup> B cells. Safety was assessed during the study. <h3>Results</h3> Baseline demographics and disease characteristics were similar among treatment arms. The ESSDAI score and MFI-20 score decreased from baseline through week 24 in telitacicept 160 mg and 240 mg groups (Figure 1A, 1B). Statistically significant improvements were observed for the ESSDAI score and MFI-20 score both at week 12 and week 24 in the telitacicept 160 mg group; statistically significant improvements were observed for the ESSDAI score at week 12 and MFI-20 score at both week 12 and week 24 in the telitacicept 240 mg group (Table 1). Telitacicept treatment produced rapid and sustained reductions in IgG, IgA, IgM and CD19<sup>+</sup> B cells (Figure 1C-F). Incidences of treatment-emergent adverse events (TEAEs) were comparable across treatment arms. Most of TEAEs were mild to moderate in severity. Serious adverse events (SAEs) were infrequent and occurred only in the placebo group. Upper respiratory tract infections were the most common infections. (Table 1) <h3>Conclusion</h3> Telitacicept showed clinical benefits and a favorable safety profile in patients with pSS. <h3>Reference</h3> [1] Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. <h3>Acknowledgements</h3> The patients and their families who participated in this study. <h3>Disclosure of Interests</h3> Dong Xu: None declared, Shangzhu Zhang: None declared, Cibo Huang: None declared, Chenghui Huang: None declared, li Qin: None declared, Xiaomei Li: None declared, Meiqing Chen: None declared, Xiumei Liu: None declared, Yi Liu: None declared, ZHIJUN LI: None declared, Jiankang Hu: None declared, Chunde Bao: None declared, Wei WEI: None declared, Jing Tian: None declared, Xinwang Duan: None declared, Ronald van Vollenhoven: None declared, Jianmin Fang Shareholder of: RemeGen Co., Ltd, Employee of: RemeGen Co., Ltd, Xiaofeng Zeng: None declared.